MAUDE Adverse Event Report: WILLIAM COOK EUROPE ZENITH ALPHA¿ THORACIC ENDOVASCULAR GRAFT PROXIMAL COMPONENTS; MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Model Number	G35359
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Perforation of Vessels (2135)
Date of Event	10/07/2021
Type of Reportable Event	Death
Additional Manufacturer Narrative
Manufacturer ref# (b)(4).Investigation is still in progress.
Event or Problem Description
Description of event according to initial reporter: complete debranching of the aortic arch all vessels re-located to the ascending aorta via open repair landing the alpha thoracic graft in the ascending aorta at the anastomosis of arch branch vessels.Physician pulled the device sheath and patient became hypotensive, physician inserted a 20fr sheath and patient became so sick that they needed to go on cardio pulmonary bypass then cpr needed to be performed and patient put on circulatory arrest.Because of cpr the sutures of the anastomosis in the arch broke requiring the anastomosis to be redone.The 20fr sheath was replaced with a 21fr cannula used for the bypass machine.Surgeon had to open abdomen because patient had developed intrabdominal compartment syndrome due to all the fluids he received through out case.When they pulled the sheath the final time his pressures plummeted again and it became clear he had a significant retroperitoneal bleed.Injury to external iliac artery believed to be caused by the delivery system even though delivered over a lunderquist wire.Additional information received 18oct2021: we had a thoracic endograft going up with fixed images after our initial angiogram.It was only suspect after the device was removed (likely tamponade) until after we removed and pressure fell.Temporized with 20 fr sheath that went back up.Further diagnosis complicated by 21 fr cardiac cannula that went up to put patient on cardiopulmonary bypass.After that sheath was removed patient had a major retroperitoneal bleed that led to the final diagnosis that was otherwise difficult to achieve (full aorto/iliac angiogram was earlier done, by cpb cannula was likely tamponoding the eia).'" patient outcome: the precurved cannula of the alpha graft dragged across the iliac causing an iliac rupture causing death of the patient.Patient passed away before getting off the operation room table.
Additional Manufacturer Narrative
Manufacturer ref# (b)(4) summary of investigational findings: a 72-year-old male underwent a tevar (thoracic endovascular aortic repair), where a zta-p-38-167-w (complaint device) was used.The patients anatomy was reported to be with focal narrowing in right access route and calcification present in external iliac and some tortuosity in right common iliac.The patient is previous known with an aneurysm on the inner curve in the aortic arch.The initial procedure was a complete debranching of the aortic arch.All vessels were relocated to the ascending aorta via open repair, landing the alpha thoracic graft in the ascending aorta at the anastomosis of arch branch vessels.The thoracic endograft was advanced with fixed images after the initial angiogram.The physician experienced resistance during the advancement of the device, likely just beyond the inguinal ligament ¿ likely the external iliac artery.The physician stopped to advance the device at the level of the iliac artery.When the physician pulled the device sheath the patient became hypotensive.To buy time the physician implanted a 20fr sheath and because of the patient¿s condition deteriorated they needed to go on cardiopulmonary bypass and therefore replaced the device with a 21fr cardiac cannula used for the bypass machine.Cpr (cardiopulmonary resuscitation) was initiated, and patient put on circulatory arrest.Because of cpr (cardiopulmonary resuscitation) the sutures of the anastomosis in the arch broke requiring the anastomosis to be redone.The surgeon had to open the abdomen because patient had developed inter-abdominal compartment syndrome due to all the fluids he received throughout the case.When the physician pulled the sheath the final time the patients¿ blood pressures plummeted again, and it became clear that the patient had a significant retroperitoneal bleed.An injury to external iliac artery believed to be caused by the delivery system even though it was delivered over a lunderquist wire.The physician thinks that the pre-curved cannula of the alpha graft dragged across the iliac artery caused an iliac rupture causing the death of the patient.Per the findings in the imaging review ¿a preoperative ct study, angiogram procedure, and device planning and sizing worksheet are provided for review along with the complaint report.An infra-renal aaa has a maximum diameter of 49 mm with diffuse irregular thrombus throughout the aorta.There is moderate tortuosity of bilateral common iliac arteries.The right cia has moderate angulation at the iliac bifurcation.The eia vessel diameter is 9.5 mm but there is focal lumen narrowing to 5.5 x 6.5 mm at the proximal segment.Heavy calcification is seen from the mid to distal eia with a minimum lumen diameter of 6 x 7.5 mm at the mid segment and 6 x 7 mm at the distal segment just past the calcification.The device planning and sizing worksheet is reviewed.The zta (38 x 167 mm) proximal component is deployed from the ascending aorta (just distal to the branch graft) to the proximal descending ta.¿ per the impressions in the imaging review: ¿the hypotensive shock upon initial removal of the delivery sheath was likely due to disruption of the right eia.This was probably temporized with placement of the larger sheath until final removal.A large retroperitoneal bleed was the likely cause of the abdominal compartment syndrome.The patient has hostile access anatomy on the preoperative imaging with a calcified and stenotic right eia and a tortuous left cia with a stent in the left eia.There is dense calcification from the mid to distal segment of the right eia and lumen narrowing with a minimum diameter of 5.5 x 6.5 mm in the proximal eia and 6 x 7 mm in the mid to distal eia.The dense calcification makes the artery less pliable for a large diameter sheath.The 18 fr delivery device has an outer diameter of 7.1 mm, so the eia was likely disrupted either during insertion or removal of the delivery sheath.An adequately stiff wire would completely straighten out the pre-curved tip of the delivery device during insertion and this should not have caused any vessel injury by scraping against the vessel wall.This would only happen if the device was delivered/removed without a guide wire or over a floppy guide wire thus allowing the tip to take its curved form.The pre-curved tip was unlikely to be the cause of the vessel disruption if a stiff wire was used¿ review of the device history file gave no indication of the device being produced out of specification.Per the instructions for use: ¿do not continue advancing the wire guide or any portion of the introduction system if resistance is felt.Stop and assess the cause of resistance; vessel, catheter, or graft damage may occur.Exercise particular care in areas of stenosis, intravascular thrombosis, or calcified or tortuous vessels.¿ and ¿adequate iliac or femoral access is required to introduce the device into the vasculature.Careful evaluation of vessel size, anatomy, and disease state is required to ensure successful sheath introduction and subsequent withdrawal, as vessels that are significantly calcified, occlusive, tortuous, or thrombus lined may preclude introduction of the endovascular graft and/ or increase the risk of embolization.¿ based on the provided information, it was not possible to determine the cause of the reported failure.However, it is likely that the rupture was the result of problems with the patient¿s anatomy ¿ i.E.Calcified and stenotic right eia.Cook medical will continue to monitor for similar events.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: ZENITH ALPHA¿ THORACIC ENDOVASCULAR GRAFT PROXIMAL COMPONENTS
• Common Device Name: MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 4632 ; DA 4632
• Manufacturer (Section G): WILLIAM COOK EUROPE; sandet 6, dk-4632; bjaeverskov
• Manufacturer Contact: lissi walmann ; sandet 6, dk-4632; bjaeverskov ; 56868686
• MDR Report Key: 12671412
• Report Number: 3002808486-2021-01890
• Device Sequence Number: 19886774
• Product Code: MIH
• UDI-Device Identifier: 10827002353593
• UDI-Public: (01)10827002353593(17)240510(10)E4106914
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P140016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/10/2024
• Device Model Number: G35359
• Device Catalogue Number: ZTA-P-38-167-W
• Device Lot Number: E4106914
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/08/2021
• Supplement Date Received by Manufacturer: 05/16/2022
• Initial Report FDA Received Date: 10/21/2021
• Supplement Report FDA Received Date: 05/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/10/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 72 YR
• Patient Sex: Male